MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA VXT W/GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 22012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

After graft transplantation, there was inflammation.The user assumed that the problem occurred elsewhere rather than the graft problem.

Manufacturer Narrative

Device not returned.

Manufacturer Narrative

Corrected b3.

Event Description

N/a.

• Brand Name: ADVANTA VXT W/GDS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8910432
• MDR Text Key: 154876236
• Report Number: 3011175548-2019-00888
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2022
• Device Model Number: 22012
• Device Catalogue Number: 22012
• Device Lot Number: 442778
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 09/10/2019; 02/01/2021
• Supplement Dates FDA Received: 09/18/2019; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention